NEO-SPACE Trial: Pembrolizumab and Chemoradiation in Nasopharyngeal Cancer

Sponsor
Chinese University of Hong Kong
Study ID
NCT03734809
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • NPC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    200mg every 3 weeks infusion

Study Details

This is an open label, single arm, non-randomized, multi-site, phase 2 clinical trial of neoadjuvant pembrolizumab in combination with gemcitabine-cisplatin for 2 cycles,followed by concurrent pembrolizumab-cisplain-radiation, and then maintainence pembrolizumab monotherpy given every 3 weeks for a total treatment duration of 12 months, in previously untreated stage IVA ( UICC 8 th Edition ) nasopharyngeal cancer(NPC).

Key Dates

Start date
May 3, 2019
Status verified
Dec 2025
Primary completion
Jan 25, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pembrolizumab
    Total 51 weeks for 17 doses of pembrolizumab: * Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab) * Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab * Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)

Primary Outcome Measure

Two-year Progression Free Survival [ Time Frame: 2 years ]

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